NELAC V1M2 Technical 2012-0717

• Audit Title

• Document No.

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• Conducted on

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  external audit

371) V1M2 5.1.1: General (ISO/IEC 17025:2005(E), Clause 5.1)

• 372) V1M2 5.1.1: Many factors determine the correctness and reliability of the tests and/or calibrations performed by a laboratory. These factors include contributions from:

• 373) V1M2 5.1.1: - human factors (5.2);

• 374) V1M2 5.1.1: - accommodation and environmental conditions (5.3);

• 375) V1M2 5.1.1: - test and calibration methods and method validation (5.4);

• 376) V1M2 5.1.1: - equipment (5.5);

• 377) V1M2 5.1.1: - measurement traceability (5.6);

• 378) V1M2 5.1.1: - sampling (5.7);

• 379) V1M2 5.1.1: - the handling of test and calibration items (5.8).

• 380) V1M2 5.1.2: The extent to which the factors contribute to the total uncertainty of measurement differs considerably between (types of) tests and between (types of) calibrations.

• 381) V1M2 5.1.2: The laboratory shall take account of these factors (V1M2 5.1.1) in developing test and calibration methods and procedures, in the training and qualification of personnel, and in the selection and calibration of the equipment it uses.

  Yes

  No

  N/A

382) V1M2 5.2: Personnel (ISO/IEC 17025:2005(E), Clause 5.2)

• 383) V1M2 5.2.1: The laboratory management shall ensure the competence of all who operate specific equipment, perform tests and/or calibrations, evaluate results, and sign test reports and calibration certificates. (See Section 1.6 of the technical modules)

• 384) V1M2 5.2.1: When using staff who are undergoing training, appropriate supervision shall be provided.

  Yes

  No

  N/A

• 385) V1M2 5.2.1: Personnel performing specific tasks shall be qualified on the basis of appropriate education, training, experience and/or demonstrated skills, as required.

  Yes

  No

  N/A

• 386) V1M2 5.2.1 N1: NOTE 1: In some technical areas (e.g. non-destructive testing) it may be required that the personnel performing certain tasks hold personnel certification. The laboratory is responsible for fulfilling specified personnel certification requirements. The requirements for personnel certification might be regulatory, included in the standards for the specific technical field, or required by the customer.

• 387) V1M2 5.2.1 N2: NOTE 2: The personnel responsible for the opinions and interpretation included in test reports should, in addition to the appropriate qualifications, training, experience and satisfactory knowledge of the testing carried out, also have:

• 388) V1M2 5.2.1 N2: — relevant knowledge of the technology used for the manufacturing of the items, materials, products, etc. tested, or the way they are used or intended to be used, and of the defects or degradations which may occur during or in service;

• 389) V1M2 5.2.1 N2: — knowledge of the general requirements expressed in the legislation and standards; and

• 390) V1M2 5.2.1 N2: — an understanding of the significance of deviations found with regard to the normal use of the items, materials, products, etc. concerned.

• 391) V1M2 5.2.2: The management of the laboratory shall formulate the goals with respect to the education, training and skills of the laboratory personnel.

  Yes

  No

  N/A

• 392) V1M2 5.2.2: The laboratory shall have a policy and procedures for identifying training needs and providing training of personnel.

  Yes

  No

  N/A

• 393) V1M2 5.2.2: The training programme shall be relevant to the present and anticipated tasks of the laboratory.

  Yes

  No

  N/A

• 394) V1M2 5.2.2: The effectiveness of the training actions taken shall be evaluated.

  Yes

  No

  N/A

• 395) V1M2 5.2.3: The laboratory shall use personnel who are employed by, or under contract to, the laboratory.

  Yes

  No

  N/A

• 396) V1M2 5.2.3: Where contracted and additional technical and key support personnel are used, the laboratory shall ensure that such personnel are supervised and competent and that they work in accordance with the laboratory's management system.

  Yes

  No

  N/A

• 397) V1M2 5.2.4: The laboratory shall maintain current job descriptions for managerial, technical and key support personnel involved in tests and/or calibrations.

  Yes

  No

  N/A

• 398) V1M2 5.2.4 N: NOTE: Job descriptions can be defined in many ways. As a minimum, the following should be defined:

• 399) V1M2 5.2.4 N: — the responsibilities with respect to performing tests and/or calibrations;

• 400) V1M2 5.2.4 N: — the responsibilities with respect to the planning of tests and/or calibrations and evaluation of results;

• 401) V1M2 5.2.4 N: — the responsibilities for reporting opinions and interpretations;

• 402) V1M2 5.2.4 N: — the responsibilities with respect to method modification and development and validation of new methods;

• 403) V1M2 5.2.4 N: — expertise and experience required;

• 404) V1M2 5.2.4 N: — qualifications and training programmes;

• 405) V1M2 5.2.4 N: — managerial duties.

• 406) V1M2 5.2.5: The management shall authorize specific personnel to perform particular types of sampling, test and/or calibration, to issue test reports and calibration certificates, to give opinions and interpretations and to operate particular types of equipment.

  Yes

  No

  N/A

• 407) V1M2 5.2.5: The laboratory shall maintain records of the relevant authorization(s), competence, educational and professional qualifications, training, skills and experience of all technical personnel, including contracted personnel.

  Yes

  No

  N/A

• 408) V1M2 5.2.5: This information shall be readily available and shall include the date on which authorization and/or competence is confirmed.

  Yes

  No

  N/A

• 409) V1M2 5.2.5 N: NOTE: All references to Calibration Certificates in ISO/IEC 17025:2005(E) are not applicable to environmental testing.

• 410) V1M2 5.2.6: Additional Personnel Requirements

• 411) V1M2 5.2.6.1: Technical Manager Qualifications

• 412) V1M2 5.2.6.1: The applicable requirements for technical managers are given below.

• 413) V1M2 5.2.6.1 a): Any technical manager of an accredited environmental laboratory engaged in chemical analysis shall be a person with a bachelor’s degree in the chemical, environmental, biological sciences, physical sciences or engineering,

  Yes

  No

  N/A

• 414) V1M2 5.2.6.1 a): Any technical manager of an accredited environmental laboratory engaged in chemical analysis shall have at least twenty-four college (24) semester credit hours in chemistry

  Yes

  No

  N/A

• 415) V1M2 5.2.6.1 a): Any technical manager of an accredited environmental laboratory engaged in chemical analysis shall have at least two (2) years of experience in the environmental analysis of representative inorganic and organic analytes for which the laboratory seeks or maintains accreditation. A master’s or doctoral degree in one of the above disciplines may be substituted for one year of experience.

  Yes

  No

  N/A

• 416) V1M2 5.2.6.1 b): Any technical manager of an accredited environmental laboratory limited to inorganic chemical analysis, other than metals analysis, shall be a person with at least an earned associate's degree in the chemical, physical or environmental sciences, or two (2) years of equivalent and successful college education,

  Yes

  No

  N/A

• 417) V1M2 5.2.6.1 b): Any technical manager of an accredited environmental laboratory limited to inorganic chemical analysis, other than metals analysis, shall have a minimum of sixteen (16) college semester credit hours in chemistry.

  Yes

  No

  N/A

• 418) V1M2 5.2.6.1 b): Any technical manager of an accredited environmental laboratory limited to inorganic chemical analysis, other than metals analysis, shall have at least two (2) years of experience performing such analysis.

  Yes

  No

  N/A

• 419) V1M2 5.2.6.1 c): Any technical manager of an accredited environmental laboratory engaged in microbiological or biological analysis shall be a person with a bachelor’s degree in microbiology, biology, chemistry, environmental sciences, physical sciences or engineering

  Yes

  No

  N/A

• 420) V1M2 5.2.6.1 c): Any technical manager of an accredited environmental laboratory engaged in microbiological or biological analysis shall have a minimum of sixteen college semester credit hours in general microbiology and biology

  Yes

  No

  N/A

• 421) V1M2 5.2.6.1 c): Any technical manager of an accredited environmental laboratory engaged in microbiological or biological analysis shall have at least two (2) years of experience in the environmental analysis of representative analytes for which the laboratory seeks or maintains accreditation. A master’s or doctoral degree in one of the above disciplines may be substituted for one (1) year of experience.

  Yes

  No

  N/A

• 422) V1M2 5.2.6.1 c): A person with an associate's degree in an appropriate field of the sciences or applied sciences, with a minimum of four (4) college semester credit hours in general microbiology may be the technical manager(s) of a laboratory engaged in microbiological analysis limited to fecal coliform, total coliform, E. coli, and standard plate count. Two (2) years of equivalent and successful college education, including the microbiology requirement, may be substituted for the associate's degree.

  Yes

  No

  N/A

• 423) V1M2 5.2.6.1 c): the technical manager(s) of a laboratory engaged in microbiological analysis limited to fecal coliform, total coliform, E. coli, and standard plate count shall have one (1) year of experience in microbiological analyses.

  Yes

  No

  N/A

• 424) V1M2 5.2.6.1 d): Any technical manager of an accredited environmental laboratory engaged in radiological analysis shall be a person with a bachelor’s degree in chemistry, environmental, biological sciences, physical sciences or engineering

  Yes

  No

  N/A

• 425) V1M2 5.2.6.1 d): Any technical manager of an accredited environmental laboratory engaged in radiological analysis shall have twenty-four (24) college semester credit hours of chemistry

  Yes

  No

  N/A

• 426) V1M2 5.2.6.1 d): Any technical manager of an accredited environmental laboratory engaged in radiological analysis shall have two (2) or more years of experience in the radiological analysis of environmental samples. A master’s or doctoral degree in one of the above disciplines may be substituted for one (1) year experience.

  Yes

  No

  N/A

• 427) V1M2 5.2.6.1 e): The technical manager(s) of an accredited environmental laboratory engaged in microscopic examination of asbestos and/or airborne fibers shall meet the following requirements:

  Yes

  No

  N/A

• 428) V1M2 5.2.6.1 e) i: The technical manager(s) of an accredited environmental laboratory engaged in microscopic examination of asbestos and/or airborne fibers requiring the use of a transmission electron microscope shall have a bachelor's degree

  Yes

  No

  N/A

• 429) V1M2 5.2.6.1 e) i: The technical manager(s) of an accredited environmental laboratory engaged in microscopic examination of asbestos and/or airborne fibers requiring the use of a transmission electron microscope shall have successfully completed of courses in the use of the instrument

  Yes

  No

  N/A

• 430) V1M2 5.2.6.1 e) i: The technical manager(s) of an accredited environmental laboratory engaged in microscopic examination of asbestos and/or airborne fibers requiring the use of a transmission electron microscope shall have one (1) year of experience, under supervision, in the use of the instrument. Such experience shall include the identification of minerals.

  Yes

  No

  N/A

• 431) V1M2 5.2.6.1 e) ii: The technical manager(s) of an accredited environmental laboratory engaged in microscopic examination of asbestos and/or airborne fibers requiring the use of a polarized light microscope, shall have an associate's degree or two (2) years of college study

  Yes

  No

  N/A

• 432) V1M2 5.2.6.1 e) ii: The technical manager(s) of an accredited environmental laboratory engaged in microscopic examination of asbestos and/or airborne fibers requiring the use of a polarized light microscope, shall have successfully completed formal coursework in polarized light microscopy

  Yes

  No

  N/A

• 433) V1M2 5.2.6.1 e) ii: The technical manager(s) of an accredited environmental laboratory engaged in microscopic examination of asbestos and/or airborne fibers requiring the use of a polarized light microscope, shall have one year of experience, under supervision, in the use of the instrument. Such experience shall include the identification of minerals.

  Yes

  No

  N/A

• 434) V1M2 5.2.6.1 e) iii: The technical manager(s) of an accredited environmental laboratory engaged in microscopic examination of asbestos and/or airborne fibers requiring the use of a phase contrast microscope, as in the determination of airborne fibers, shall have an associate's degree or two (2) years of college study

  Yes

  No

  N/A

• 435) V1M2 5.2.6.1 e) iii: The technical manager(s) of an accredited environmental laboratory engaged in microscopic examination of asbestos and/or airborne fibers requiring the use of a phase contrast microscope, as in the determination of airborne fibers, shall have documentation of successful completion of formal coursework in phase contrast microscopy

  Yes

  No

  N/A

• 436) V1M2 5.2.6.1 e) iii: The technical manager(s) of an accredited environmental laboratory engaged in microscopic examination of asbestos and/or airborne fibers requiring the use of a phase contrast microscope, as in the determination of airborne fibers, shall have one (1) year of experience, under supervision, in the use of the instrument.

  Yes

  No

  N/A

• 437) V1M2 5.2.6.1 f): Any technical manager of an accredited environmental laboratory engaged in the examination of radon in air shall have at least an associate’s degree or two (2) years of college

  Yes

  No

  N/A

• 438) V1M2 5.2.6.1 f): Any technical manager of an accredited environmental laboratory engaged in the examination of radon in air shall have at least one (1) year of experience in radiation measurements

  Yes

  No

  N/A

• 439) V1M2 5.2.6.1 f): Any technical manager of an accredited environmental laboratory engaged in the examination of radon in air shall have at least one (1) year of experience in the measurement of radon and/or radon progeny.

  Yes

  No

  N/A

• 440) V1M2 5.2.6.2: Technical Manager Qualification Exceptions

• 441) V1M2 5.2.6.2 a): Notwithstanding any other provision of this Section, a full-time employee of a drinking water or sewage treatment facility who holds a valid treatment plant operator's certificate appropriate to the nature and size of such facility shall be deemed to meet the educational requirements as the technical manager.

  Yes

  No

  N/A

• 442) V1M2 5.2.6.2 a): A technical manager shall have two (2) year testing experience devoted exclusively to the testing of environmental samples specified in the scope of the facility’s regulatory permit.

  Yes

  No

  N/A

• 443) V1M2 5.2.6.2 a): Such accreditation for a water treatment facility and/or a sewage treatment facility shall be limited to the scope of that facility’s regulatory permit.

  Yes

  No

  N/A

• 444) V1M2 5.2.6.2 b): A full-time employee of an industrial waste treatment facility with a minimum of two (2) years of experience under supervision in testing of environmental samples taken within such facility for the scope of that facility’s regulatory permit shall be deemed to meet the requirements for serving as the technical manager of an accredited laboratory.

  Yes

  No

  N/A

• 445) V1M2 5.2.6.2 b): Such accreditation for an industrial waste treatment facility shall be limited to the scope of that facility’s regulatory permit.

  Yes

  No

  N/A

• 446) V1M2 5.2.6.2 c): Persons who do not meet the education credential requirements but possess the requisite experience of 5.2.6.1 shall qualify as technical manager(s) subject to the following conditions.

  Yes

  No

  N/A

• 447) V1M2 5.2.6.2 c) i: Persons who do not meet the education credential requirements but possess the requisite experience of 5.2.6.1 shall qualify as technical manager(s) if the person shall be a technical manager of the laboratory on the date the laboratory applies for accreditation and/or becomes subject to accreditation under this Standard

  Yes

  No

  N/A

• 448) V1M2 5.2.6.2 c) i: Persons who do not meet the education credential requirements but possess the requisite experience of 5.2.6.1 shall qualify as technical manager(s) if the person shall have been a technical manager in that laboratory continuously for the previous twelve (12) months or more.

  Yes

  No

  N/A

• 449) V1M2 5.2.6.2 c) ii: Persons who do not meet the education credential requirements but possess the requisite experience of 5.2.6.1 shall be approved as a technical manager for only those fields of accreditation for which he/she has been technical manager in that laboratory for the previous twelve (12) months or more.

  Yes

  No

  N/A

• 450) V1M2 5.2.6.2 c) iii: A person who is admitted as a technical manager under these conditions, and leaves the laboratory, will be eligible for hire as a technical manager for the same fields of accreditation in another accredited laboratory.

  Yes

  No

  N/A

• 451) V1M2 5.2.7: Data Integrity Training

• 452) V1M2 5.2.7: Data integrity training shall be provided as a formal part of new employee orientation and shall also be provided on an annual basis for all current employees.

  Yes

  No

  N/A

• 453) V1M2 5.2.7: Employees are required to understand that any infractions of the laboratory data integrity procedures shall result in a detailed investigation that could lead to very serious consequences including immediate termination, debarment or civil/criminal prosecution.

  Yes

  No

  N/A

• 454) V1M2 5.2.7: The initial data integrity training and the annual refresher training shall have a signature attendance sheet or other form of documentation that demonstrates all staff have participated and understand their obligations related to data integrity.

  Yes

  No

  N/A

• 455) V1M2 5.2.7: Data integrity training requires emphasis on the importance of proper written narration on the part of the analyst with respect to those cases where analytical data may be useful, but are in one sense or another partially deficient

  Yes

  No

  N/A

• 456) V1M2 5.2.7: The topics covered in such training shall be documented in writing (such as an agenda) and provided to all trainees.

  Yes

  No

  N/A

• 457) V1M2 5.2.7: At a minimum, the following topics and activities shall be included:

• 458) V1M2 5.2.7.a: organizational mission and its relationship to the critical need for honesty and full disclosure in all analytical reporting, how and when to report data integrity issues, and record keeping;

  Yes

  No

  N/A

• 459) V1M2 5.2.7.b: training, including discussion regarding all data integrity procedures;

  Yes

  No

  N/A

• 460) V1M2 5.2.7.c: data integrity training documentation;

  Yes

  No

  N/A

• 461) V1M2 5.2.7.d: in-depth data monitoring and data integrity procedure documentation; and

  Yes

  No

  N/A

• 462) V1M2 5.2.7.e: specific examples of breaches of ethical behavior such as improper data manipulations, adjustments of instrument time clocks, and inappropriate changes in concentrations of standards.

  Yes

  No

  N/A

• 463) V1M2 5.2.7: The data integrity procedures may also include written ethics agreements, examples of improper practices, examples of improper chromatographic manipulations, requirements for external ethics program training, and any external resources available to employees.

  Yes

  No

  N/A

464) V1M2 5.3: Accommodation and Environmental Conditions (ISO/IEC 17025:2005(E), Clause 5.3)

• 465) V1M2 5.3.1: Laboratory facilities for testing and/or calibration, including but not limited to energy sources, lighting and environmental conditions, shall be such as to facilitate correct performance of the tests and/or calibrations.

  Yes

  No

  N/A

• 466) V1M2 5.3.1: The laboratory shall ensure that the environmental conditions do not invalidate the results or adversely affect the required quality of any measurement.

  Yes

  No

  N/A

• 467) V1M2 5.3.1: Particular care shall be taken when sampling and tests and/or calibrations are undertaken at sites other than a permanent laboratory facility.

  Yes

  No

  N/A

• 468) V1M2 5.3.1: The technical requirements for accommodation and environmental conditions that can affect the results of tests and calibrations shall be documented.

  Yes

  No

  N/A

• 469) V1M2 5.3.2: The laboratory shall monitor, control and record environmental conditions as required by the relevant specifications, methods and procedures or where they influence the quality of the results.

  Yes

  No

  N/A

• 470) V1M2 5.3.2: Due attention shall be paid, for example, to biological sterility, dust, electromagnetic disturbances, radiation, humidity, electrical supply, temperature, and sound and vibration levels, as appropriate to the technical activities concerned.

  Yes

  No

  N/A

• 471) V1M2 5.3.2: Tests and calibrations shall be stopped when the environmental conditions jeopardize the results of the tests and/or calibrations.

  Yes

  No

  N/A

• 472) V1M2 5.3.3: There shall be effective separation between neighbouring areas in which there are incompatible activities.

  Yes

  No

  N/A

• 473) V1M2 5.3.3: Measures shall be taken to prevent cross-contamination.

  Yes

  No

  N/A

• 474) V1M2 5.3.4: Access to and use of areas affecting the quality of the tests and/or calibrations shall be controlled.

  Yes

  No

  N/A

• 475) V1M2 5.3.4: The laboratory shall determine the extent of control based on its particular circumstances.

  Yes

  No

  N/A

• 476) V1M2 5.3.5: Measures shall be taken to ensure good housekeeping in the laboratory.

  Yes

  No

  N/A

• 477) V1M2 5.3.5: Special procedures shall be prepared where necessary.

  Yes

  No

  N/A

478) V1M2 5.4: Environmental Test Methods and Method Validation

• 479) V1M2 5.4 N: NOTE: All references to Calibration Laboratories and Calibration Methods in ISO/IEC 17025:2005(E) in these Clauses are not applicable to environmental testing.

• 480) V1M2 5.4.1: General (ISO/IEC 17025:2005(E), Clause 5.4.1)

• 481) V1M2 5.4.1: The laboratory shall use appropriate methods and procedures for all tests and/or calibrations within its scope.

  Yes

  No

  N/A

• 482) V1M2 5.4.1: These include sampling, handling, transport, storage and preparation of items to be tested and/or calibrated, and, where appropriate, an estimation of the measurement uncertainty as well as statistical techniques for analysis of test and/or calibration data.

  Yes

  No

  N/A

• 483) V1M2 5.4.1: The laboratory shall have instructions on the use and operation of all relevant equipment, and on the handling and preparation of items for testing and/or calibration, or both, where the absence of such instructions could jeopardize the results of tests and/or calibrations.

  Yes

  No

  N/A

• 484) V1M2 5.4.1: All instructions, standards, manuals and reference data relevant to the work of the laboratory shall be kept up to date and shall be made readily available to personnel (see 4.3).

  Yes

  No

  N/A

• 485) V1M2 5.4.1: Deviation from test and calibration methods shall occur only if the deviation has been documented, technically justified, authorized, and accepted by the customer.

  Yes

  No

  N/A

• 486) V1M2 5.4.1 N: NOTE: International, regional or national standards or other recognized specifications that contain sufficient and concise information on how to perform the tests and/or calibrations do not need to be supplemented or rewritten as internal procedures if these standards are written in a way that they can be used as published by the operating staff in a laboratory. It may be necessary to provide additional documentation for optional steps in the method or additional details.

• 487) V1M2 5.4.2: Selection of Methods (ISO/IEC 17025:2005(E), Clause 5.4.2)

• 488) V1M2 5.4.2: The laboratory shall use test and/or calibration methods, including methods for sampling, which meet the needs of the customer and which are appropriate for the tests and/or calibrations it undertakes.

  Yes

  No

  N/A

• 489) V1M2 5.4.2: Methods published in international, regional or national standards shall preferably be used.

  Yes

  No

  N/A

• 490) V1M2 5.4.2: The laboratory shall ensure that it uses the latest valid edition of a standard unless it is not appropriate or possible to do so.

  Yes

  No

  N/A

• 491) V1M2 5.4.2: When necessary, the standard shall be supplemented with additional details to ensure consistent application.

  Yes

  No

  N/A

• 492) V1M2 5.4.2: When the customer does not specify the method to be used, the laboratory shall select appropriate methods that have been published either in international, regional or national standards, or by reputable technical organizations, or in relevant scientific texts or journals, or as specified by the manufacturer of the equipment.

  Yes

  No

  N/A

• 493) V1M2 5.4.2: Laboratory-developed methods or methods adopted by the laboratory may also be used if they are appropriate for the intended use and if they are validated.

  Yes

  No

  N/A

• 494) V1M2 5.4.2: The customer shall be informed as to the method chosen.

  Yes

  No

  N/A

• 495) V1M2 5.4.2: The laboratory shall confirm that it can properly operate standard methods before introducing the tests or calibrations.

  Yes

  No

  N/A

• 496) V1M2 5.4.2: If the standard method changes, the confirmation shall be repeated.

  Yes

  No

  N/A

• 497) V1M2 5.4.2: The laboratory shall inform the customer when the method proposed by the customer is considered to be inappropriate or out of date.

  Yes

  No

  N/A

• 498) V1M2 5.4.3: Laboratory-Developed Methods (ISO/IEC 17025:2005(E), Clause 5.4.3)

• 499) V1M2 5.4.3: The introduction of test and calibration methods developed by the laboratory for its own use shall be a planned activity and shall be assigned to qualified personnel equipped with adequate resources.

  Yes

  No

  N/A

• 500) V1M2 5.4.3: Plans shall be updated as development proceeds and effective communication amongst all personnel involved shall be ensured.

  Yes

  No

  N/A

• 501) V1M2 5.4.4: Non-Standard Methods (ISO/IEC 17025:2005(E), Clause 5.4.4) is not applicable in this module and is addressed in specific technical modules based on technology.

• 502) V1M2 5.4.5: Validation of Methods (ISO/IEC 17025:2005(E), Clause 5.4.5) is not applicable in this module and is addressed in specific technical modules based on technology.

• 503) V1M2 5.4.6: Estimation of Analytical Uncertainty

• 504) V1M2 5.4.6: Clause 5.4.6 of the ISO/IEC/IEC 17025:2005(E) concerning calibration testing does not apply. The following requirement replaces the ISO/IEC Clause.

• 505) V1M2 5.4.6: Environmental testing laboratories shall have a procedure(s) for estimating analytical uncertainty.

  Yes

  No

  N/A

• 506) V1M2 5.4.6: Quality control measurement data may be used to determine analytical uncertainty.

  Yes

  No

  N/A

• 507) V1M2 5.4.7: Control of Data (ISO/IEC 17025:2005(E), Clause 5.4.7)

• 508) V1M2 5.4.7.1: Calculations and data transfers shall be subject to appropriate checks in a systematic manner.

  Yes

  No

  N/A

• 509) V1M2 5.4.7.2: When computers or automated equipment are used for the acquisition, processing, recording, reporting, storage or retrieval of test or calibration data, the laboratory shall ensure that:

• 510) V1M2 5.4.7.2.a: computer software developed by the user is documented in sufficient detail

  Yes

  No

  N/A

• 511) V1M2 5.4.7.2.a: computer software developed by the user is suitably validated as being adequate for use;

  Yes

  No

  N/A

• 512) V1M2 5.4.7.2.b: procedures are established and implemented for protecting the data;

  Yes

  No

  N/A

• 513) V1M2 5.4.7.2.b: such procedures shall include, but not be limited to, integrity and confidentiality of data entry or collection, data storage, data transmission and data processing;

  Yes

  No

  N/A

• 514) V1M2 5.4.7.2.c: computers and automated equipment are maintained to ensure proper functioning

  Yes

  No

  N/A

• 515) V1M2 5.4.7.2.c: computers and automated equipment are provided with the environmental and operating conditions necessary to maintain the integrity of test and calibration data.

  Yes

  No

  N/A

• 516) V1M2 5.4.7.2 N: NOTE: Commercial off-the-shelf software (e.g. word processing, database and statistical programmes) in general use within their designed application range may be considered to be sufficiently validated. However, laboratory software configuration/modifications should be validated as in 5.4.7.2 a).

517) V1M2 5.5: Calibration Requirements (ISO/IEC 17025:2005(E), Clause 5.5)

• 518) V1M2 5.5.1: The laboratory shall be furnished with all items of sampling, measurement and test equipment required for the correct performance of the tests and/or calibrations (including sampling, preparation of test and/or calibration items, processing and analysis of test and/or calibration data).

  Yes

  No

  N/A

• 519) V1M2 5.5.1: In those cases where the laboratory needs to use equipment outside its permanent control, it shall ensure that the requirements of this International Standard are met.

  Yes

  No

  N/A

• 520) V1M2 5.5.2: Equipment and its software used for testing, calibration and sampling shall be capable of achieving the accuracy required and shall comply with specifications relevant to the tests and/or calibrations concerned.

  Yes

  No

  N/A

• 521) V1M2 5.5.2: Calibration programmes shall be established for key quantities or values of the instruments where these properties have a significant effect on the results.

  Yes

  No

  N/A

• 522) V1M2 5.5.2: Before being placed into service, equipment (including that used for sampling) shall be calibrated or checked to establish that it meets the laboratory's specification requirements and complies with the relevant standard specifications.

  Yes

  No

  N/A

• 523) V1M2 5.5.2: It (equipment) shall be checked and/or calibrated before use (see 5.6).

  Yes

  No

  N/A

• 524) V1M2 5.5.3: Equipment shall be operated by authorized personnel.

  Yes

  No

  N/A

• 525) V1M2 5.5.3: Up-to-date instructions on the use and maintenance of equipment (including any relevant manuals provided by the manufacturer of the equipment) shall be readily available for use by the appropriate laboratory personnel.

  Yes

  No

  N/A

• 526) V1M2 5.5.4: Each item of equipment and its software used for testing and calibration and significant to the result shall, when practicable, be uniquely identified.

  Yes

  No

  N/A

• 527) V1M2 5.5.5: Records shall be maintained of each item of equipment and its software significant to the tests and/or calibrations performed.

  Yes

  No

  N/A

• 528) V1M2 5.5.5: The records shall include at least the following:

• 529) V1M2 5.5.5.a: the identity of the item of equipment

  Yes

  No

  N/A

• 530) V1M2 5.5.5.a: the identity of the software;

  Yes

  No

  N/A

• 531) V1M2 5.5.5.b: the manufacturer's name

  Yes

  No

  N/A

• 532) V1M2 5.5.5.b: type identification

  Yes

  No

  N/A

• 533) V1M2 5.5.5.b: and serial number or other unique identification;

  Yes

  No

  N/A

• 534) V1M2 5.5.5.c: checks that equipment complies with the specification (see 5.5.2);

  Yes

  No

  N/A

• 535) V1M2 5.5.5.d: the current location, where appropriate;

  Yes

  No

  N/A

• 536) V1M2 5.5.5.e: the manufacturer's instructions, if available, or reference to their location;

  Yes

  No

  N/A

• 537) V1M2 5.5.5.f: dates, results and copies of reports and certificates of all calibrations

  Yes

  No

  N/A

• 538) V1M2 5.5.5.f: dates, results and copies of reports and certificates of all adjustments

  Yes

  No

  N/A

• 539) V1M2 5.5.5.f: dates, results and copies of reports and certificates of all acceptance criteria

  Yes

  No

  N/A

• 540) V1M2 5.5.5.f: the due date of next calibration;

  Yes

  No

  N/A

• 541) V1M2 5.5.5.g: the maintenance plan, where appropriate

  Yes

  No

  N/A

• 542) V1M2 5.5.5.g: and maintenance carried out to date;

  Yes

  No

  N/A

• 543) V1M2 5.5.5.h: any damage, malfunction, modification or repair to the equipment.

  Yes

  No

  N/A

• 544) V1M2 5.5.6: The laboratory shall have procedures for safe handling, transport, storage, use and planned maintenance of measuring equipment to ensure proper functioning and in order to prevent contamination or deterioration.

  Yes

  No

  N/A

• 545) V1M2 5.5.6 N: NOTE: Additional procedures may be necessary when measuring equipment is used outside the permanent laboratory for tests, calibrations or sampling.

• 546) V1M2 5.5.7: Equipment that has been subjected to overloading or mishandling, gives suspect results, or has been shown to be defective or outside specified limits, shall be taken out of service

  Yes

  No

  N/A

• 547) V1M2 5.5.7: It (equipment) shall be isolated to prevent its use or clearly labelled or marked as being out of service until it has been repaired and shown by calibration or test to perform correctly.

  Yes

  No

  N/A

• 548) V1M2 5.5.7: The laboratory shall examine the effect of the defect or departure from specified limits on previous tests and/or calibrations and shall institute the "Control of nonconforming work" procedure (see 4.9).

  Yes

  No

  N/A

• 549) V1M2 5.5.8: Whenever practicable, all equipment under the control of the laboratory and requiring calibration shall be labelled, coded or otherwise identified to indicate the status of calibration

  Yes

  No

  N/A

• 550) V1M2 5.5.8: Whenever practicable, all equipment under the control of the laboratory and requiring calibration shall be labelled, coded or otherwise identified to indicate the date when last calibrated

  Yes

  No

  N/A

• 551) V1M2 5.5.8: Whenever practicable, all equipment under the control of the laboratory and requiring calibration shall be labelled, coded or otherwise identified to indicate the date or expiration criteria when recalibration is due.

  Yes

  No

  N/A

• 552) V1M2 5.5.9: When, for whatever reason, equipment goes outside the direct control of the laboratory, the laboratory shall ensure that the function and calibration status of the equipment are checked and shown to be satisfactory before the equipment is returned to service.

  Yes

  No

  N/A

• 553) V1M2 5.5.10: When intermediate checks are needed to maintain confidence in the calibration status of the equipment, these checks shall be carried out according to a defined procedure.

  Yes

  No

  N/A

• 554) V1M2 5.5.11: Where calibrations give rise to a set of correction factors, the laboratory shall have procedures to ensure that copies (e.g. in computer software) are correctly updated.

  Yes

  No

  N/A

• 555) V1M2 5.5.12: Test and calibration equipment, including both hardware and software, shall be safeguarded from adjustments which would invalidate the test and/or calibration results.

  Yes

  No

  N/A

• 556) V1M2 5.5.12 N: NOTE: ISO/IEC Clauses 5.5.1 to 5.5.12 apply with respect to equipment in environmental testing laboratories.

• 557) V1M2 5.5.13: Additional Requirements and Clarifications

• 558) V1M2 5.5.13: Calibration requirements for analytical support equipment are included in this Section while requirements for instrument (testing) calibration are included in technical modules (i.e., Asbestos, Chemistry, Microbiology, Radiochemistry and Toxicology).

• 559) V1M2 5.5.13.1: Support Equipment

• 560) V1M2 5.5.13.1: This Standard applies to all devices that may not be the actual test instrument, but are necessary to support laboratory operations. These include, but are not limited to: balances, ovens, refrigerators, freezers, incubators, water baths, temperature measuring devices (including thermometers and thermistors), thermal/pressure sample preparation devices and volumetric dispensing devices (such as Eppendorf® or automatic dilutor/dispensing devices), if quantitative results are dependent on their accuracy, as in standard preparation and dispensing or dilution into a specified volume.

• 561) V1M2 5.5.13.1.a: All support equipment shall be maintained in proper working order.

  Yes

  No

  N/A

• 562) V1M2 5.5.13.1.a: The records of all repair and maintenance activities, including service calls, shall be kept.

  Yes

  No

  N/A

• 563) V1M2 5.5.13.1.b: All support equipment shall be calibrated or verified at least annually, using a recognized National Metrology Institute, such as NIST, traceable references when available, bracketing the range of use.

  Yes

  No

  N/A

• 564) V1M2 5.5.13.1.b: The results of such calibration or verification shall be within the specifications required of the application for which this equipment is used or:

  Yes

  No

  N/A

• 565) V1M2 5.5.13.1.b.i: i. the equipment shall be removed from service until repaired; or

  Yes

  No

  N/A

• 566) V1M2 5.5.13.1.b.ii: ii. the laboratory shall maintain records of established correction factors to correct all measurements.

  Yes

  No

  N/A

• 567) V1M2 5.5.13.1.c: Raw data records shall be retained to document equipment performance.

  Yes

  No

  N/A

• 568) V1M2 5.5.13.1.d: On each day the equipment is used, balances, ovens, refrigerators, freezers and water baths shall be checked and documented.

  Yes

  No

  N/A

• 569) V1M2 5.5.13.1.d: The acceptability for use or continued use shall be according to the needs of the analysis or application for which the equipment is being used.

  Yes

  No

  N/A

• 570) V1M2 5.5.13.1.e: Volumetric dispensing devices (except Class A glassware and Glass microliter syringes) shall be checked for accuracy on a quarterly basis.

  Yes

  No

  N/A

571) V1M2 5.6: Measurement Traceability

• 572) V1M2 5.6.1: General (ISO/IEC 17025:2005(E), Clause 5.6.1) is not applicable to environmental testing.

• 573) V1M2 5.6.2: Specific Requirements (ISO/IEC 17025:2005(E), Clause 5.6.2) is not applicable to environmental testing.

• 574) V1M2 5.6.3: Reference Standards and Reference Materials (ISO/IEC 17025:2005(E), Clause 5.6.3)

• 575) V1M2 5.6.3.1: Reference Standards

• 576) V1M2 5.6.3.1: The laboratory shall have a programme and procedure for the calibration of its reference standards.

  Yes

  No

  N/A

• 577) V1M2 5.6.3.1: Reference standards shall be calibrated by a body that can provide traceability as described in 5.6.2.1.

  Yes

  No

  N/A

• 578) V1M2 5.6.3.1: Such reference standards of measurement held by the laboratory shall be used for calibration only and for no other purpose, unless it can be shown that their performance as reference standards would not be invalidated.

  Yes

  No

  N/A

• 579) V1M2 5.6.3.1: Reference standards shall be calibrated before and after any adjustment.

  Yes

  No

  N/A

• 580) V1M2 5.6.3.2: Reference Materials

• 581) V1M2 5.6.3.2: Reference materials shall, where possible, be traceable to SI units of measurement, or to certified reference materials

  Yes

  No

  N/A

• 582) V1M2 5.6.3.2: Internal reference materials shall be checked as far as is technically and economically practicable.

  Yes

  No

  N/A

• 583) V1M2 5.6.3.3: Intermediate Checks

• 584) V1M2 5.6.3.3: Checks needed to maintain confidence in the calibration status of reference, primary, transfer or working standards and reference materials shall be carried out according to defined procedures and schedules.

  Yes

  No

  N/A

• 585) V1M2 5.6.3.4: Transport and Storage

• 586) V1M2 5.6.3.4: The laboratory shall have procedures for safe handling, transport, storage and use of reference standards and reference materials in order to prevent contamination or deterioration and in order to protect their integrity.

  Yes

  No

  N/A

• 587) V1M2 5.6.3.4 N: NOTE: Additional procedures may be necessary when reference standards and reference materials are used outside the permanent laboratory for tests, calibrations or sampling.

• 588) V1M2 5.6.4: Additional Requirements and Clarifications

• 589) V1M2 5.6.4.1: Reference Standards and Reference Materials

• 590) V1M2 5.6.4.1: The laboratory shall provide satisfactory evidence of correlation of results, for example, by participation in a suitable program of inter-laboratory comparisons, proficiency testing, or independent analysis.

  Yes

  No

  N/A

• 591) V1M2 5.6.4.1.a: Reference Standards

• 592) V1M2 5.6.4.1.a: Where commercially available, this traceability shall be to a national standard of measurement.

  Yes

  No

  N/A

• 593) V1M2 5.6.4.1.b: Reference Materials

• 594) V1M2 5.6.4.1.b: Where possible, traceability shall be to national or international standards of measurement or to national or international standard reference materials.

  Yes

  No

  N/A

• 595) V1M2 5.6.4.1.b: Internal reference materials shall be checked as far as is technically and economically practicable.

  Yes

  No

  N/A

• 596) V1M2 5.6.4.2: Documentation and Labeling of Standards, Reagents, and Reference Materials

• 597) V1M2 5.6.4.2: Documented procedures shall exist for the purchase, receipt and storage of consumable materials used for the technical operations of the laboratory.

  Yes

  No

  N/A

• 598) V1M2 5.6.4.2.a: The laboratory shall retain records for all standards, reagents, reference materials, and media, including the manufacturer/vendor

  Yes

  No

  N/A

• 599) V1M2 5.6.4.2.a: The laboratory shall retain records for all standards, reagents, reference materials, and media, including the manufacturer’s Certificate of Analysis or purity (if available)

  Yes

  No

  N/A

• 600) V1M2 5.6.4.2.a: The laboratory shall retain records for all standards, reagents, reference materials, and media, including the date of receipt

  Yes

  No

  N/A

• 601) V1M2 5.6.4.2.a: The laboratory shall retain records for all standards, reagents, reference materials, and media, including recommended storage conditions.

  Yes

  No

  N/A

• 602) V1M2 5.6.4.2.b: For original containers, if an expiration date is provided by the manufacturer or vendor it shall be recorded on the container. If an expiration date is not provided by the manufacturer or vendor it is not required.

  Yes

  No

  N/A

• 603) V1M2 5.6.4.2.c: Records shall be maintained on standard, reference material, and reagent preparation. These records shall indicate traceability to purchased stocks or neat compounds, reference to the method of preparation, date of preparation, expiration date and preparer's initials

  Yes

  No

  N/A

• 604) V1M2 5.6.4.2.d: All containers of prepared standards, reference materials, and reagents shall bear a unique identifier

  Yes

  No

  N/A

• 605) V1M2 5.6.4.2.d: All containers of prepared standards, reference materials, and reagents shall bear an expiration date.

  Yes

  No

  N/A

• 606) V1M2 5.6.4.2.e: Procedures shall be in place to ensure prepared reagents meet the requirements of the method.

  Yes

  No

  N/A

• 607) V1M2 5.6.4.2.f: Standards, reference materials, and reagents shall not be used after their expiration dates unless their reliability is verified by the laboratory.

  Yes

  No

  N/A

608) V1M2 5.7: Collection of Samples (ISO/IEC 17025:2005(E), Clause 5.7)

• 609) V1M2 5.7.1: The laboratory shall have a sampling plan and procedures for sampling when it carries out sampling of substances, materials or products for subsequent testing or calibration.

  Yes

  No

  N/A

• 610) V1M2 5.7.1: The sampling plan as well as the sampling procedure shall be available at the location where sampling is undertaken.

  Yes

  No

  N/A

• 611) V1M2 5.7.1: Sampling plans shall, whenever reasonable, be based on appropriate statistical methods.

  Yes

  No

  N/A

• 612) V1M2 5.7.1: The sampling process shall address the factors to be controlled to ensure the validity of the test and calibration results.

  Yes

  No

  N/A

• 613) V1M2 5.7.1 N1: NOTE 1: Sampling is a defined procedure whereby a part of a substance, material or product is taken to provide for testing or calibration of a representative sample of the whole. Sampling may also be required by the appropriate specification for which the substance, material or product is to be tested or calibrated. In certain cases (e.g. forensic analysis), the sample may not be representative but is determined by availability.

• 614) V1M2 5.7.1 N2: NOTE 2: Sampling procedures should describe the selection, sampling plan, withdrawal and preparation of a sample or samples from a substance, material or product to yield the required information.

• 615) V1M2 5.7.2: Where the customer requires deviations, additions or exclusions from the documented sampling procedure, these shall be recorded in detail with the appropriate sampling data

  Yes

  No

  N/A

• 616) V1M2 5.7.2: Where the customer requires deviations, additions or exclusions from the documented sampling procedure, these shall be included in all documents containing test and/or calibration results

  Yes

  No

  N/A

• 617) V1M2 5.7.2: Where the customer requires deviations, additions or exclusions from the documented sampling procedure, these shall be communicated to the appropriate personnel.

  Yes

  No

  N/A

• 618) V1M2 5.7.3: The laboratory shall have procedures for recording relevant data and operations relating to sampling that forms part of the testing or calibration that is undertaken.

  Yes

  No

  N/A

• 619) V1M2 5.7.3: These records shall include the sampling procedure used, the identification of the sampler, environmental conditions (if relevant) and diagrams or other equivalent means to identify the sampling location as necessary and, if appropriate, the statistics the sampling procedures are based upon.

  Yes

  No

  N/A

• 620) V1M2 5.7.4: Additional Requirements

• 621) V1M2 5.7.4.a: Documentation shall include the date of sampling.

  Yes

  No

  N/A

• 622) V1M2 5.7.4.a: Documentation shall include the time of sampling.

  Yes

  No

  N/A

• 623) V1M2 5.7.4.b: Any deviations from sampling procedures shall be documented.

  Yes

  No

  N/A

624) V1M2 5.8: Handling Samples and Test Items (ISO/IEC 17025:2005(E), Clause 5.8)

• 625) V1M2 5.8.1: The laboratory shall have procedures for the transportation, receipt, handling, protection, storage, retention and/or disposal of test and/or calibration items, including all provisions necessary to protect the integrity of the test or calibration item, and to protect the interests of the laboratory and the customer.

  Yes

  No

  N/A

• 626) V1M2 5.8.2: The laboratory shall have a system for identifying test and/or calibration items.

  Yes

  No

  N/A

• 627) V1M2 5.8.2: The identification shall be retained throughout the life of the item in the laboratory.

  Yes

  No

  N/A

• 628) V1M2 5.8.2: The system shall be designed and operated so as to ensure that items cannot be confused physically or when referred to in records or other documents.

  Yes

  No

  N/A

• 629) V1M2 5.8.2: The system shall, if appropriate, accommodate a sub-division of groups of items and the transfer of items within and from the laboratory.

  Yes

  No

  N/A

• 630) V1M2 5.8.3: Upon receipt of the test or calibration item, abnormalities or departures from normal or specified conditions, as described in the test or calibration method, shall be recorded

  Yes

  No

  N/A

• 631) V1M2 5.8.3: When there is doubt as to the suitability of an item for test or calibration, or when an item does not conform to the description provided, or the test or calibration required is not specified in sufficient detail, the laboratory shall consult the customer for further instructions before proceeding and shall record the discussion.

  Yes

  No

  N/A

• 632) V1M2 5.8.4: The laboratory shall have procedures and appropriate facilities for avoiding deterioration, loss or damage to the test or calibration item during storage, handling and preparation.

  Yes

  No

  N/A

• 633) V1M2 5.8.4: Handling instructions provided with the item shall be followed.

  Yes

  No

  N/A

• 634) V1M2 5.8.4: When items have to be stored or conditioned under specified environmental conditions, these conditions shall be maintained, monitored and recorded.

  Yes

  No

  N/A

• 635) V1M2 5.8.4: Where a test or calibration item or a portion of an item is to be held secure, the laboratory shall have arrangements for storage and security that protect the condition and integrity of the secured items or portions concerned.

  Yes

  No

  N/A

• 636) V1M2 5.8.4 N1: NOTE 1: Where test items are to be returned into service after testing, special care is required to ensure that they are not damaged or injured during the handling, testing or storing/waiting processes.

• 637) V1M2 5.8.4 N2: NOTE 2: A sampling procedure and information on storage and transport of samples, including information on sampling factors influencing the test or calibration result, should be provided to those responsible for taking and transporting the samples.

• 638) V1M2 5.8.4 N3: NOTE 3: Reasons for keeping a test or calibration item secure can be for reasons of record, safety or value, or to enable complementary tests and/or calibrations to be performed later.

• 639) V1M2 5.8.5: Additional Requirements - Documentation

• 640) V1M2 5.8.5: The following are essential to ensure the validity of the laboratory’s data.

• 641) V1M2 5.8.5.a: The laboratory shall have a documented system for uniquely identifying the samples to be tested, to ensure that there can be no confusion regarding the identity of such samples at any time.

  Yes

  No

  N/A

• 642) V1M2 5.8.5.a: This system shall include identification for all samples, sub-samples, preservations, sample containers, tests, and subsequent extracts and/or digestates.

  Yes

  No

  N/A

• 643) V1M2 5.8.5.b: This laboratory code shall maintain an unequivocal link with the unique field ID code assigned to each sample.

  Yes

  No

  N/A

• 644) V1M2 5.8.5.c: The laboratory ID code shall be placed as a durable mark on the sample container.

  Yes

  No

  N/A

• 645) V1M2 5.8.5.d: The laboratory ID code shall be entered into the laboratory records

  Yes

  No

  N/A

• 646) V1M2 5.8.5.d: The laboratory ID code shall be the link that associates the sample with related laboratory activities such as sample preparation.

  Yes

  No

  N/A

• 647) V1M2 5.8.5.e: In cases where the sample collector and analyst are the same individual, or the laboratory pre-assigns numbers to sample containers, the laboratory ID code may be the same as the field ID code.

  Yes

  No

  N/A

• 648) V1M2 5.8.6: Additional Requirements - Sample Acceptance Policy

• 649) V1M2 5.8.6: The laboratory shall have a written sample acceptance policy that includes the following:

  Yes

  No

  N/A

• 650) V1M2 5.8.6.a: proper, full, and complete documentation, which shall include sample identification

  Yes

  No

  N/A

• 651) V1M2 5.8.6.a: proper, full, and complete documentation, which shall include the location of collection

  Yes

  No

  N/A

• 652) V1M2 5.8.6.a: proper, full, and complete documentation, which shall include the date of collection

  Yes

  No

  N/A

• 653) V1M2 5.8.6.a: proper, full, and complete documentation, which shall include the time of collection

  Yes

  No

  N/A

• 654) V1M2 5.8.6.a: proper, full, and complete documentation, which shall include collector's name

  Yes

  No

  N/A

• 655) V1M2 5.8.6.a: proper, full, and complete documentation, which shall include preservation type

  Yes

  No

  N/A

• 656) V1M2 5.8.6.a: proper, full, and complete documentation, which shall include sample type

  Yes

  No

  N/A

• 657) V1M2 5.8.6.a: proper, full, and complete documentation, which shall include any special remarks concerning the sample;

  Yes

  No

  N/A

• 658) V1M2 5.8.6.b: proper sample labeling to include unique identification

  Yes

  No

  N/A

• 659) V1M2 5.8.6.b: proper sample labeling to include a labeling system for the samples with requirements concerning the durability of the labels (water resistant) and the use of indelible ink;

  Yes

  No

  N/A

• 660) V1M2 5.8.6.c: use of appropriate sample containers;

  Yes

  No

  N/A

• 661) V1M2 5.8.6.d: adherence to specified holding times;

  Yes

  No

  N/A

• 662) V1M2 5.8.6.e: sufficient sample volume to perform the necessary tests;

  Yes

  No

  N/A

• 663) V1M2 5.8.6.f: procedures to be used when samples show signs of damage, contamination or inadequate preservation; and

  Yes

  No

  N/A

• 664) V1M2 5.8.6.g: qualification of any data that do not meet the above requirements.

  Yes

  No

  N/A

• 665) V1M2 5.8.7: Additional Requirements - Sample Receipt Protocols

• 666) V1M2 5.8.7.1: The laboratory shall implement procedures for verifying and documenting preservation.

  Yes

  No

  N/A

• 667) V1M2 5.8.7.2: If the sample does not meet the sample receipt acceptance criteria listed in this Standard, the laboratory shall either:

• 668) V1M2 5.8.7.2.a: retain correspondence and/or records of conversations concerning the final disposition of rejected samples; or

  Yes

  No

  N/A

• 669) V1M2 5.8.7.2.b: fully document any decision to proceed with the analysis of samples not meeting acceptance criteria.

  Yes

  No

  N/A

• 670) V1M2 5.8.7.2.i: The condition of these samples shall be noted on the chain of custody or transmittal form and laboratory receipt documents.

  Yes

  No

  N/A

• 671) V1M2 5.8.7.2.ii: The analysis data shall be appropriately qualified on the final report.

  Yes

  No

  N/A

• 672) V1M2 5.8.7.3: The laboratory shall utilize a permanent chronological record such as a logbook or electronic database to document receipt of all sample containers.

  Yes

  No

  N/A

• 673) V1M2 5.8.7.3.a: This sample receipt log shall record the following:

• 674) V1M2 5.8.7.3.a.i: client/project name,

  Yes

  No

  N/A

• 675) V1M2 5.8.7.3.a.ii: date and time of laboratory receipt,

  Yes

  No

  N/A

• 676) V1M2 5.8.7.3.a.iii: unique laboratory ID code, and

  Yes

  No

  N/A

• 677) V1M2 5.8.7.3.a.iv: signature or initials of the person making the entries.

  Yes

  No

  N/A

• 678) V1M2 5.8.7.3.b: During the login process, the following information shall be unequivocally linked to the log record or included as a part of the log.

  Yes

  No

  N/A

• 679) V1M2 5.8.7.3.b: If such information is recorded/documented elsewhere, the records shall be part of the laboratory's permanent records, easily retrievable upon request and readily available to individuals who will process the sample.

  Yes

  No

  N/A

• 680) V1M2 5.8.7.3.b N: NOTE: The placement of the laboratory ID number on the sample container is not considered a permanent record.

  Yes

  No

  N/A

• 681) V1M2 5.8.7.3.b.i: The field ID code, which identifies each sample, shall be linked to the laboratory ID code in the sample receipt log.

  Yes

  No

  N/A

• 682) V1M2 5.8.7.3.b.ii: The date and time of sample collection shall be linked to the sample and to the date and time of receipt in the laboratory.

  Yes

  No

  N/A

• 683) V1M2 5.8.7.3.b.iii: The requested analyses (including applicable approved method numbers) shall be linked to the laboratory ID code.

  Yes

  No

  N/A

• 684) V1M2 5.8.7.3.b.iv: Any comments resulting from inspection for sample rejection shall be linked to the laboratory ID code.

  Yes

  No

  N/A

• 685) V1M2 5.8.7.4: All documentation, such as memos, chain of custody, or transmittal forms that are transmitted to the laboratory by the sample transmitter, shall be retained.

  Yes

  No

  N/A

• 686) V1M2 5.8.7.5: A complete chain of custody record form, if utilized, shall be maintained.

  Yes

  No

  N/A

• 687) V1M2 5.8.8: Additional Requirements - Legal Chain of Custody Protocols

• 688) V1M2 5.8.8: Legal chain of custody procedures are used for evidentiary or legal purposes.

• 689) V1M2 5.8.8: If a client specifies that a sample is to be used for evidentiary purposes, then a laboratory shall have a written SOP for how that laboratory will carry out legal chain of custody.

  Yes

  No

  N/A

• 690) V1M2 5.8.9: Additional Requirements - Sample Storage and Disposal

• 691) V1M2 5.8.9.a: Samples shall be stored according to the conditions specified by preservation protocols.

  Yes

  No

  N/A

• 692) V1M2 5.8.9.a.i: Samples that require thermal preservation shall be stored under refrigeration that is +/-2°C of the specified preservation temperature unless regulatory or method specific criteria exist.

  Yes

  No

  N/A

• 693) V1M2 5.8.9.a.i: For samples with a specified storage temperature of 4°C, storage at a temperature above the freezing point of water to 6°C shall be acceptable.

  Yes

  No

  N/A

• 694) V1M2 5.8.9.a.ii: Samples shall be stored away from all standards, reagents, and food. Samples shall be stored in such a manner to prevent cross contamination.

  Yes

  No

  N/A

• 695) V1M2 5.8.9.b: Sample fractions, extracts, leachates and other sample preparation products shall be stored according to Section 5.8.9 a) above or according to specifications in the method.

  Yes

  No

  N/A

• 696) V1M2 5.8.9.c: The laboratory shall have SOPs for the disposal of samples, digestates, leachates and extracts or other sample preparation products.

  Yes

  No

  N/A

697) V1M2 5.9: Quality Assurance for Environmental Testing (ISO/IEC 17025:2005(E), Clause 5.9)

• 698) V1M2 5.9.1: The laboratory shall have quality control procedures for monitoring the validity of tests and calibrations undertaken.

  Yes

  No

  N/A

• 699) V1M2 5.9.1: The resulting data shall be recorded in such a way that trends are detectable and, where practicable, statistical techniques shall be applied to the reviewing of the results.

  Yes

  No

  N/A

• 700) V1M2 5.9.1: This monitoring shall be planned and reviewed and may include, but not be limited to, the following:

  Yes

  No

  N/A

• 701) V1M2 5.9.1.a: regular use of certified reference materials and/or internal quality control using secondary reference materials;

  Yes

  No

  N/A

• 702) V1M2 5.9.1.b: participation in interlaboratory comparison or proficiency-testing programmes;

  Yes

  No

  N/A

• 703) V1M2 5.9.1.c: replicate tests or calibrations using the same or different methods;

  Yes

  No

  N/A

• 704) 5.9.1.d: retesting or recalibration of retained items;

  Yes

  No

  N/A

• 705) V1M2 5.9.1.e: correlation of results for different characteristics of an item.

  Yes

  No

  N/A

• 706) V1M2 5.9.1.e N: NOTE: The selected methods should be appropriate for the type and volume of the work undertaken.

• 707) V1M2 5.9.2: Quality control data shall be analysed and, where they are found to be outside pre-defined criteria, planned action shall be taken to correct the problem and to prevent incorrect results from being reported.

  Yes

  No

  N/A

• 708) V1M2 5.9.3: Essential Quality Control Procedures

• 709) V1M2 5.9.3: These general quality control principles shall apply, where applicable, to all testing laboratories. The manner in which they are implemented is dependent on the types of tests performed by the laboratory (i.e., asbestos, chemical, microbiological, radiological, toxicity) and are further described in Technical Modules. The standards for any given test type shall assure that the applicable principles are addressed:

• 710) V1M2 5.9.3.a: All laboratories shall have detailed written protocols in place to monitor the following quality controls:

  Yes

  No

  N/A

• 711) V1M2 : i. through viii are specified for the technologies identified in the technical modules. These should be used if the laboratory is using a technology other than those specified in Modules 3 through 7

• 712) V1M2 5.9.3.a.i: positive and negative controls (see technical modules), chemical or microbiological as applicable to the test type, to monitor tests such as blanks, matrix spikes, reference toxicants;

• 713) V1M2 5.9.3.a.ii: tests to define the variability and/or repeatability of the laboratory results such as replicates;

• 714) V1M2 5.9.3.a.iii: measures to assure the accuracy of the method including calibration and/or continuing calibrations, use of certified reference materials, proficiency test samples, or other measures;

• 715) V1M2 5.9.3.a.iv: measures to evaluate method capability, such as limit of detection and limit of quantitation or range of applicability such as linearity;

• 716) V1M2 5.9.3.a.v: selection of appropriate formulae to reduce raw data to final results such as regression analysis, comparison to internal/external standard calculations, and statistical analyses;

• 717) V1M2 5.9.3.a.vi: selection and use of reagents and standards of appropriate quality;

• 718) V1M2 5.9.3.a.vii: measures to assure the selectivity of the test for its intended purpose; and

• 719) V1M2 5.9.3.a.viii: measures to assure constant and consistent test conditions (both instrumental and environmental) where required by the method such as temperature, humidity, light or specific instrument conditions.

• 720) V1M2 5.9.3.b: All quality control measures shall be assessed and evaluated on an on-going basis and quality control acceptance criteria shall be used.

  Yes

  No

  N/A

• 721) V1M2 5.9.3.c: The laboratory shall have procedures for the development of acceptance/rejection criteria where no method or regulatory criteria exist.

  Yes

  No

  N/A

• 722) V1M2 5.9.3.c: The quality control protocols specified by the laboratory’s SOP shall be followed (see Section 4.2.8.5 in this Standard).

  Yes

  No

  N/A

• 723) V1M2 5.9.3.c: The laboratory shall ensure that the essential standards outlined in Technical Modules or mandated methods or regulations (whichever are more stringent) are incorporated into their method manuals.

  Yes

  No

  N/A

• 724) V1M2 5.9.3.c: When it is not apparent which is more stringent, the QC in the mandated method or regulations is to be followed.

  Yes

  No

  N/A

725) V1M2 5.10: Reporting the Results

• 726) V1M2 5.10 N: NOTE: All references to Calibration Certificates in ISO/IEC 17025:2005 are not applicable to environmental testing.

• 727) V1M2 5.10.1: General (ISO/IEC 17025:2005(E), Clause 5.10.1)

• 728) V1M2 5.10.1: The results of each test, calibration, or series of tests or calibrations carried out by the laboratory shall be reported accurately, clearly, unambiguously and objectively, and in accordance with any specific instructions in the test or calibration methods.

  Yes

  No

  N/A

• 729) V1M2 5.10.1: The results shall be reported, usually in a test report or a calibration certificate (see Note 1), and shall include all the information requested by the customer and necessary for the interpretation of the test or calibration results and all information required by the method used. This information is normally that required by 5.10.2, and 5.10.3 or 5.10.4.

  Yes

  No

  N/A

• 730) V1M2 5.10.1: In the case of tests or calibrations performed for internal customers, or in the case of a written agreement with the customer, the results may be reported in a simplified way.

  Yes

  No

  N/A

• 731) V1M2 5.10.1: Any information listed in 5.10.2 to 5.10.4 which is not reported to the customer shall be readily available in the laboratory which carried out the tests and/or calibrations.

  Yes

  No

  N/A

• 732) V1M2 5.10.1 N1: NOTE 1: Test reports and calibration certificates are sometimes called test certificates and calibration reports respectively.

• 733) V1M2 5.10.1 N2: NOTE 2: The test reports or calibration certificates may be issued as hard copy or by electronic data transfer provided that the requirements of this International Standard are met.

• 734) V1M2 5.10.2: Test Reports and Calibration Certificates (ISO/IEC 17025:2005(E), Clause 5.10.2)

• 735) V1M2 5.10.2: Each test report or calibration certificate shall include at least the following information, unless the laboratory has valid reasons for not doing so:

• 736) V1M2 5.10.2.a: a title (e.g. "Test Report" or "Calibration Certificate");

  Yes

  No

  N/A

• 737) V1M2 5.10.2.b: the name and address of the laboratory, and the location where the tests and/or calibrations were carried out, if different from the address of the laboratory;

  Yes

  No

  N/A

• 738) V1M2 5.10.2.c: unique identification of the test report or calibration certificate (such as the serial number), and on each page an identification in order to ensure that the page is recognized as a part of the test report or calibration certificate, and a clear identification of the end of the test report or calibration certificate;

  Yes

  No

  N/A

• 739) V1M2 5.10.2.d: the name and address of the customer;

  Yes

  No

  N/A

• 740) V1M2 5.10.2.e: identification of the method used;

  Yes

  No

  N/A

• 741) V1M2 5.10.2.f: a description of, the condition of, and unambiguous identification of the item(s) tested or calibrated;

  Yes

  No

  N/A

• 742) V1M2 5.10.2.g: the date of receipt of the test or calibration item(s) where this is critical to the validity and application of the results, and the date(s) of performance of the test or calibration;

  Yes

  No

  N/A

• 743) V1M2 5.10.2.h: reference to the sampling plan and procedures used by the laboratory or other bodies where these are relevant to the validity or application of the results;

  Yes

  No

  N/A

• 744) V1M2 5.10.2.i: the test or calibration results with, where appropriate, the units of measurement;

  Yes

  No

  N/A

• 745) V1M2 5.10.2.j: the name(s), function(s) and signature(s) or equivalent identification of person(s) authorizing the test report or calibration certificate;

  Yes

  No

  N/A

• 746) V1M2 5.10.2.k: where relevant, a statement to the effect that the results relate only to the items tested or calibrated.

  Yes

  No

  N/A

• 747) V1M2 5.10.2 N1: NOTE 1: Hard copies of test reports and calibration certificates should also include the page number and total number of pages.

• 748) V1M2 5.10.2 N2: NOTE 2: It is recommended that laboratories include a statement specifying that the test report or calibration certificate shall not be reproduced except in full, without written approval of the laboratory.

• 749) V1M2 5.10.3: Test Reports (ISO/IEC 17025:2005(E), Clause 5.10.3)

• 750) V1M2 5.10.3.1: In addition to the requirements listed in 5.10.2, test reports shall, where necessary for the interpretation of the test results, include the following:

• 751) V1M2 5.10.3.1.a: deviations from, additions to, or exclusions from the test method, and information on specific test conditions, such as environmental conditions;

  Yes

  No

  N/A

• 752) V1M2 5.10.3.1.b: where relevant, a statement of compliance/non-compliance with requirements and/or specifications;

  Yes

  No

  N/A

• 753) V1M2 5.10.3.1.c: where applicable, a statement on the estimated uncertainty of measurement; information on uncertainty is needed in test reports when it is relevant to the validity or application of the test results, when a customer's instruction so requires, or when the uncertainty affects compliance to a specification limit;

  Yes

  No

  N/A

• 754) V1M2 5.10.3.1.d: where appropriate and needed, opinions and interpretations (see 5.10.5);

  Yes

  No

  N/A

• 755) V1M2 5.10.3.1.e: additional information which may be required by specific methods, customers or groups of customers.

  Yes

  No

  N/A

• 756) V1M2 5.10.3.2: In addition to the requirements listed in 5.10.2 and 5.10.3.1, test reports containing the results of sampling shall include the following, where necessary for the interpretation of test results:

  Yes

  No

  N/A

• 757) V1M2 5.10.3.2.a: the date of sampling;

  Yes

  No

  N/A

• 758) V1M2 5.10.3.2.b: unambiguous identification of the substance, material or product sampled (including the name of the manufacturer, the model or type of designation and serial numbers as appropriate);

  Yes

  No

  N/A

• 759) V1M2 5.10.3.2.c: the location of sampling, including any diagrams, sketches or photographs;

  Yes

  No

  N/A

• 760) V1M2 5.10.3.2.d: a reference to the sampling plan and procedures used;

  Yes

  No

  N/A

• 761) V1M2 5.10.3.2.e: details of any environmental conditions during sampling that may affect the interpretation of the test results;

  Yes

  No

  N/A

• 762) V1M2 5.10.3.2.f: any standard or other specification for the sampling method or procedure, and deviations, additions to or exclusions from the specification concerned.

  Yes

  No

  N/A

• 763) V1M2 5.10.4: Calibration Certificates (ISO/IEC 17025:2005(E), Clause 5.10.4) does not apply to environmental testing activities.

• 764) V1M2 5.10.5: Opinions and interpretations

• 765) V1M2 5.10.5: When opinions and interpretations are included, the laboratory shall document the basis upon which the opinions and interpretations have been made. Opinions and interpretations shall be clearly marked as such in a test report.

  Yes

  No

  N/A

• 766) V1M2 5.10.5 N1: NOTE 1: Opinions and interpretations should not be confused with inspections and product certifications as intended in ISO/IEC 17020 and ISO/IEC Guide 65.

• 767) V1M2 5.10.5 N2: NOTE 2: Opinions and interpretations included in a test report may comprise, but not be limited to, the following:

• 768) V1M2 5.10.5: • an opinion on the statement of compliance/noncompliance of the results with requirements;

• 769) V1M2 5.10.5: • fulfilment of contractual requirements;

• 770) V1M2 5.10.5: • recommendations on how to use the results;

• 771) V1M2 5.10.5: • guidance to be used for improvements.

• 772) V1M2 5.10.5 N3: NOTE 3: In many cases it might be appropriate to communicate the opinions and interpretations by direct dialogue with the customer. Such dialogue should be written down.

• 773) V1M2 5.10.6: Testing and calibration results obtained from subcontractors

• 774) V1M2 5.10.6: When the test report contains results of tests performed by subcontractors, these results shall be clearly identified.

  Yes

  No

  N/A

• 775) V1M2 5.10.6: The subcontractor shall report the results in writing or electronically. When a calibration has been subcontracted, the laboratory performing the work shall issue the calibration certificate to the contracting laboratory.

  Yes

  No

  N/A

• 776) V1M2 5.10.7: Electronic transmission of results

• 777) V1M2 5.10.7: In the case of transmission of test or calibration results by telephone, telex, facsimile or other electronic or electromagnetic means, the requirements of this International Standard shall be met (see also 5.4.7).

  Yes

  No

  N/A

• 778) V1M2 5.10.8: Format of reports and certificates

• 779) V1M2 5.10.8: The format shall be designed to accommodate each type of test or calibration carried out and to minimize the possibility of misunderstanding or misuse.

  Yes

  No

  N/A

• 780) V1M2 5.10.8 N1: NOTE 1: Attention should be given to the lay-out of the test report or calibration certificate, especially with regard to the presentation of the test or calibration data and ease of assimilation by the reader.

• 781) V1M2 5.10.8 N2: NOTE 2: The headings should be standardized as far as possible.

• 782) V1M2 5.10.9: Amendments to test reports and calibration certificates

• 783) V1M2 5.10.9: Material amendments to a test report or calibration certificate after issue shall be made only in the form of a further document, or data transfer, which includes the statement: “Supplement to Test Report [or Calibration Certificate], serial number... [or as otherwise identified]”, or an equivalent form of wording.

  Yes

  No

  N/A

• 784) V1M2 5.10.9: Such amendments shall meet all the requirements of this International Standard.

  Yes

  No

  N/A

• 785) V1M2 5.10.9: When it is necessary to issue a complete new test report or calibration certificate, this shall be uniquely identified and shall contain a reference to the original that it replaces.

  Yes

  No

  N/A

• 786) V1M2 5.10.10: Exceptions

• 787) V1M2 5.10.10: Some regulatory reporting requirements or formats, such as monthly operating reports, may not require all items listed below; however, the laboratory shall provide all the required information to their client for use in preparing such regulatory reports.

  Yes

  No

  N/A

• 788) V1M2 5.10.10: Laboratories operated solely to provide data for compliance purposes (in-house or captive laboratories) shall have all applicable information specified in Section 5.10 readily available for review by the accreditation body.

  Yes

  No

  N/A

• 789) V1M2 5.10.10: However, formal reports detailing the information are not required if:

  Yes

  No

  N/A

• 790) V1M2 5.10.10.a: the in-house laboratory is itself responsible for preparing the regulatory reports; or

  Yes

  No

  N/A

• 791) 5.10.10.b: the laboratory provides information to another individual within the organization for preparation of regulatory reports. The facility management shall ensure that the appropriate report items are in the report to the regulatory authority, if such information is required; or

  Yes

  No

  N/A

• 792) 5.10.10.c: see Section 5.10.1, paragraph 3.

• 793) 5.10.11: Additional Requirements

• 794) 5.10.11.a: Time of sample preparation and/or analysis if the required holding time for either activity is less than or equal to seventy-two hours.

  Yes

  No

  N/A

• 795) 5.10.11.b: Results that are reported on a basis other than as received (e. g., dry weight).

  Yes

  No

  N/A

• 796) 5.10.11.c: Any non-accredited tests shall be clearly identified as such to the client when claims of accreditation to this Standard are made in the analytical report or in the supporting electronic or hardcopy deliverables.

  Yes

  No

  N/A

• 797) 5.10.11.d: Clear identification of numerical results with values outside the calibration range.

  Yes

  No

  N/A

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